Status:
COMPLETED
Efavirenz or Atazanavir/Ritonavir Given With Emtricitabine/Tenofovir Disoproxil Fumarate or Abacavir/Lamivudine in HIV Infected Treatment-Naive Adults
Lead Sponsor:
Advancing Clinical Therapeutics Globally for HIV/AIDS and Other Infections
Collaborating Sponsors:
National Institute of Allergy and Infectious Diseases (NIAID)
Conditions:
HIV Infections
Eligibility:
All Genders
16+ years
Phase:
PHASE3
Brief Summary
Currently, the preferred anti-HIV regimens used in the United States consist of two nucleoside reverse transcriptase inhibitors (NRTIs) and the nonnucleoside reverse transcriptase inhibitor (NNRTI) ef...
Detailed Description
Antiretroviral (ARV) treatment regimens consisting of EFV and two NRTIs are the most commonly prescribed regimens for the initial therapy of HIV-infected people in the United States. Such regimens are...
Eligibility Criteria
Inclusion
- HIV-infected. A resistance assay must be obtained if the participant has evidence of recent infection. More information on this criterion can be found in the protocol.
- Antiretroviral naive, defined as 7 days or less of ARV treatment at any time prior to study entry. Participants who have received ARVs as part of postexposure prophylaxis or who have received an investigational drug that was not an NRTI, NNRTI, or PI are eligible for this study.
- HIV viral load greater than 1,000 copies/ml within 90 days prior to study entry
- Certain laboratory values obtained within 30 days prior to study entry. More information on this criterion can be found in the protocol
- Willing to use acceptable forms of contraception
- Parent or guardian able and willing to provide written informed consent, if applicable
- Hepatitis B surface antigen (HBsAg) negative at study entry
Exclusion
- Immunomodulators (e.g., interleukins, interferons, cyclosporine), HIV vaccine, systemic cytotoxic chemotherapy, or investigational therapy within 30 days prior to study entry. Individuals receiving either stable physiologic glucocorticoid doses, corticosteroids for acute therapy for pneumocystis pneumonia, or a short course (2 weeks or less) of pharmacologic glucocorticoid therapy will not be excluded.
- Known allergy/sensitivity to study drugs or their formulations
- Active alcohol or drug use that, in the opinion of the investigator, would interfere with adherence to study requirements
- Serious illness requiring systemic treatment or hospitalization. Patients who have completed therapy or are clinically stable on therapy for at least 7 days prior to study entry are not excluded.
- Known clinically relevant cardiac conduction system disease
- Requirement for any current medications that are prohibited with any study treatment.
- Evidence of any major drug resistance-associated mutation on any genotype or evidence of significant resistance on any phenotype performed at any time prior to study entry.
- Current imprisonment or involuntary incarceration for psychiatric or physical (e.g., infectious disease) illness
- Breastfeeding. Women who become pregnant during the study will be unblinded and required to permanently discontinue their study regimens.
Key Trial Info
Start Date :
September 1 2005
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
November 1 2009
Estimated Enrollment :
1864 Patients enrolled
Trial Details
Trial ID
NCT00118898
Start Date
September 1 2005
End Date
November 1 2009
Last Update
October 12 2018
Active Locations (52)
Enter a location and click search to find clinical trials sorted by distance.
1
Usc Crs (1201)
Los Angeles, California, United States, 90033
2
UCLA CARE Center CRS (601)
Los Angeles, California, United States, 90035
3
Stanford CRS (501)
Palo Alto, California, United States, 94304
4
Ucsd, Avrc Crs (701)
San Diego, California, United States, 92103